No sample was returned for investigation.Manufacturing review of the referenced lot number and respective device history record was conducted on 18may2021, showing that all units were quality released on 28dec2020 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m20f1184 was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 07july2020 having met all quality requirements including product sterility testing following eo sterilization, as well as internal bioburden and product pyrogen (lal) testing requirements.In lieu of a request for the oem supplier for a dhr review of the ecm material lots, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.A review of the instructions for use (ifu-art-20662c) provided with the finished cangaroo envelope device states under the section potential complications: the following device-related complications are possible: hematoma and infection.The patient's history mentions several vascular access ports as well as the possibility that she is a cancer patient.Reported adverse events potentially related to treatments for associated comorbidities.No further information is available reqarding this event, should any additional information be received, a follow-up report will be filed.
|
It was reported on (b)(6) 2021 by aziyo business partner biotronik that a cangaroo envelope (model cmcv-009-med, lot# m20n1418) was used in an initial pacemaker implant procedure on (b)(6) 2021 on a female patient.Envelope was prepared by soaking in saline for 1 - 2 minutes.Patient was seen in emergency department on (b)(6) 2021 with swelling and bruising around her pacemaker and potential envelope infection.The patient was placed on iv antibiotics.Device was explanted (b)(6) 2021 and patient is being re-evaluated if another device will be implanted at a later date.No further information was provided despite requests for additional details.Should any additional information be received, a follow-up report will be filed.
|